Popular painkiller: Acetaminophen is the active ingredient in Tylenol.

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Stick to low-dose Tylenol, FDA says

Article by: Karen Kaplan

Los Angeles Times

January 15, 2014 - 10:11 PM

LOS ANGELES — The Food and Drug Administration has asked doctors, dentists, pharmacists and other health care professionals to stop giving patients high-dose acetaminophen, the active ingredient in the popular pain-reliever Tylenol.

Pills, capsules, tablets, syrups and other formulations that contain more than 325 milligrams of acetaminophen have not been shown to reduce pain better than lower doses.

However, such high levels of the drug can be dangerous, the FDA said.

Pharmacists who are asked to fill prescriptions for medications with more than 325 mg of acetaminophen should contact the doctor or dentist who ordered it and see if a lower dose would suffice, the agency said.

The new limits will “reduce the risk of severe liver injury from inadvertent acetaminophen overdose,” the FDA said.

The FDA warned consumers about the risk of overdoses of acetaminophen when they simultaneously take several drugs that contain it.

The National Institutes of Health says acetaminophen overdose “is one of the most common poisonings worldwide.”

Reducing the maximum dose of acetaminophen also should reduce the risk of an accidental overdose because almost half of such cases involve a prescription medication, the FDA said.

The recommendation won’t immediately affect over-the-counter products with acetaminophen, but the FDA said it will address those products “in another regulatory action.”

Some of the products available without prescriptions contain 500 milligrams of the painkiller. The FDA said it’s “easy to take too much” when consumers combine pain and fever medication with cough and cold remedies.

Over-the-counter products that contain acetaminophen already warn on their labels about the risk of liver damage.

Patients who have too much acetaminophen in their systems can suffer liver failure, since that organ is responsible for metabolizing the drug. Consequences of liver failure include the need for a liver transplant and death.

As explained by Harvard Medical School’s Family Health Guide, most acetaminophen is broken down into harmless substances that are removed from the body in urine.

“But a small percentage is rendered into a compound that’s extremely harmful to cells,” the guide says.

The compound is combined with an antioxidant called glutathione to make it safe to ingest. In an overdose, there’s “not enough glutathione to sop up” the compound, making liver damage a threat.

Three years ago, FDA regulators asked drugmakers to voluntarily reduce the amount of acetaminophen in powerful medicines such as Percocet and Vicodin that also contain opioids or other painkillers.

Physicians and dentists often prescribe those drugs to patients after surgery, serious injuries or dental procedures.

The FDA had set a target date of Jan. 14, 2014, for the voluntary reductions.

More than half of the manufacturers contacted this week had complied with the request, the agency said.

Regulators will take steps to withdraw their approval of drugs containing more than 325 mg of acetaminophen “in the near future,” the FDA said.